Information for Healthcare Professionals

ReceptivaDxTM is a new and improved non-surgical test for endometrial receptivity that provides enhanced screening for ALL stages of endometriosis and other conditions that interfere with implantation. This is the first test for endometriosis with high sensitivity and specificity (96%), especially useful in women with unexplained IVF failure or infertility. While other tests evaluate the quality of embryos or determine optimal embryo transfer windows, only ReceptivaDxTM can accurately detect inflammatory conditions on the uterine lining likely to cause implantation issues

The test specifically identifies BCL6, a gene repressor biomarker that is present in the setting of inflammation. BCL6 is dramatically over-expressed in women with endometriosis, making it a likely candidate for the cause of progesterone resistance that contributes to implantation problems (read blog post). Progesterone is required for normal pregnancy, so a protein that interferes with progesterone action would explain much about the problems encountered in women with endometriosis.

Studies have shown that women with elevated BCL6 results are 5 times less likely to succeed in IVF or subsequent transfer attempts. A negative BCL6 result provides reassurance to patients that endometriosis is not of concern

A recent cohort study in the December 2017 issue of Fertility and Sterility demonstrated the prognostic value of BCL6 results in predicting the likelihood of a live birth on the next IVF transfer on patients presenting with unexplained infertility before transfer.

Frequently Asked Questions

Treatment protocols at IVF centers typically treat with 60-90 days of GnRH agonists like Depot Lupron(R) followed by embryo transfer 5 to 6 days following oocyte retrieval (in fresh cycles) or during programmed estrogen/progesterone uterine replacement cycles (in frozen embryo transfers- FET cycles). For those opting for surgical laparoscopy, excision or ablation of suspected endometriosis was performed followed by management and advancement to IVF or FET. A recently published paper in the Journal of Assisted Reproduction and Genetics outlines the similar success of either laparoscopy or Depot Lupron (60 days) compared to untreated positive BCL6 women. In this 7 year study, live birth rates went from around 10% in untreated patients to over 50% in treated. For new users of ReceptivaDx, we are happy to provide references to those centers with an established track record of treatment or a conversation with the study authors.

Candidates include:

  • All women with unexplained infertility
  • Women who have failed one or more IVF cycles
  • Women with limited embryo reserves
  • Women who have experienced recurrent pregnancy loss
  • Women who cannot afford IVF or that have limited fertility coverage

The ReceptivaDx Test is performed on an endometrial biopsy sample and sent to one of our accredited pathology labs with extensive experience in Immunohistochemistry (IHC) testing. Results are faxed back to the sending IFV center in 7-10 days.

Samples are stable at room temperature during the entire shipping process and can be collected any day of the week. Biopsy timing information is provided below. Our ReceptivaDx collection kit comes complete with everything necessary to properly collect and submit a sample.

Yes: Defining Your ReceptivaDx Biopsy Date Range:

Natural Cycle:
6-10 days after LH surge
7-10 days after ovulation occurs

Mock Cycle:
5-10 days after start of progesterone

Once collected, the sample is placed in a preservative (10% formalin vial) and is sent overnight via FedEx to our testing facility. Results are available typically within 3-4 business days.

The cost of the ReceptivaDx test is $690 dollars. This includes all associated kit and shipping costs using FedEx overnight. CD138, a marker that identifies endometritis and Beta3 Integrin, a marker for overall uterine receptivity can also be ordered for an additional $125 per marker.

Payment via credit card is required at the time of sample submission. Patients may call our offices to make payment in advance if preferred. CiceroDx provides a detailed receipt that can be used for potential reimbursement from insurance or healthcare spending accounts. Please provide an email address on the test request form to receive the detailed receipt.

International customers are responsible for the cost of shipping to our testing centers in the US.

Cicero is in the process of collecting success rates from multiple centers using this test for at least one year. Initial results from many of our centers with significant volume show success rates mimicking or exceeding the results recently published in a 7 year prospective study here. Moving a high percentage of failed IVF patients from a 10% success rate untreated to over a 50% live birth rate after treatment has moved these center’s overall averages up significantly with some centers exceeding 70% and greater. If your center would like to be included or see the aggregate statistics, it will be available mid 2019. Please contact us.

While both tests are taken from an endometrial biopsy, the tests differ completely in their purpose. The ERA (Endometrial Receptivity Analysis) is a genetic test that evaluates the expression of genes to find the optimal embryo transfer window. The ReceptivaDx test identifies the underlying cause of UI, endometriosis. While the quality of embryos and optimal embryo transfer windows are important, if inflammation caused by endometriosis is present, IVF failure is likely.

CiceroDx, Inc. is a diagnostics company dedicated to the advancement of clinical assays in women’s healthcare. CiceroDx has exclusive rights to BCL6 analysis on endometrial tissue. Our company has forged relationships with key academic research centers and is dedicated to the development of new testing modalities for endometriosis and unexplained infertility. CiceroDx maintains two laboratory locations in the US. Both testing sites operate under CLIA guidelines established for best laboratory practices and are fully licensed. CiceroDx is the only licensed provider in the US for detection of the BCL6 marker in endometrial biopsy samples.

Please feel free to contact us at 800-795-5385 for further information. International clients can email us at info@cicerodx.com or call us at 1-714-951-9245.

The ReceptivaDxTM Test was developed by CiceroDx in conjunction with Pathology Consultants, Inc. of Greenville, SC. Pathology Consultants, Inc. is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). As with other laboratory-developed tests, this testing service has not been cleared or approved by the US FDA or any other federal regulatory agencies. Data have not been submitted to or evaluated by Federal regulatory agencies and the test is not for sale as an In Vitro Diagnostic (IVD) in the US or the EU.

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